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FiltraLinX® Semi-automatic TFF System

The semi-automatic TFF system adopts a modular design and is available in benchtop and floor-standing models. It is equipped with filter holders of different specifications. According to process requirements, the circulation pump can be flexibly configured with a rotor pump or a diaphragm pump.

The system is designed to be compact and practical. With automatic feedback and adjustment of the flow rate and pressure, the automatic control of TMP and Delta P is available, thereby realizing the automatic operations of concentration, diafiltration, desalting, and dealcoholizing of biological products such as antibodies, vaccines, blood products, and gene therapy drugs.

Due to its automatic operation, cost-effectiveness, and compliance with regulations related to data integrity, the system is an ideal choice for filtration systems in pilot-scale manufacturing, medical product manufacturing for clinical use, and the GMP manufacturing phase for some products, especially for polyvalent pneumococcal vaccines, blood products, gene therapy medicines, and cell therapy drugs.


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Features of FiltraLinX® Semi-Automatic TFF System

  • Available in various specifications: Standard benchtop model for 0.1–0.5 m2 cassettes; standard benchtop model for 0.5–2.5 m2 cassettes; floor-standing models for different cassette sizes, even 200 m2 and above.

  • PLC, weighing unit, manual valve, circulation pump, flow meter, pressure sensor, supporting feedback control of TMP and Delta P, to facilitate automatic manufacturing.

  • Compatible with both the ultrafiltration cassettes and hollow fiber filters.

  • Filtration tank (available in PP and 316L stainless steel) with window, compatible with single-use mixing and storage bags for sample loading and collection.

  • Feeding pump for equal-volume diafiltration.

  • Siemens 12-in HMI panel.

  • Software operation interface in Chinese/English, loaded with Chinese input methods.

  • Emergency stop button.

  • Hierarchical alarm.

  • Three-tier access control.

  • Comply with the requirements on electronic record and electronic signature management in FDA 21 CFR Part 11.

  • Comply with audit trail requirements.

  • Display of process parameter trend charts with reports in PDF format.

  • Reserved cassette integrity detection interface.

  • Reserved SCADA system data interface.

  • Optional instruments: online pH, online conductivity, and online UV.

  • Optional functions: CIP and water flux detection.


semi automatic tff system

Specifications of FiltraLinX® Semi-Automatic TFF System

Semi-Automatic System Configuration and Specifications

Membrane

area

0.1–0.5 m2

0.5–2.5 m22.5–5 m25–10 m22.5–20 m2

Cat. No.

TS-CMV-S03TS-CMV-S20TS-CMV-Q40TS-CMV-L30

TS-CMV-L67

Automatic

level

Automatic control

Max. operating pressure


5 bar

Max. back pressure

6 bar

Tubing

SS 316L Ra ≤ 0.4 μm

Sanitary connection

TC

Manual valve

PP, SS 316L

Pressure detection

0–6 bar

Flow detection

Permeate end, electromagnetic flow meter; retentate end, electromagnetic flow meter

Electrical unit

SIEMENS S7

Operation

mode

Automatic recording and analysis by software

Operating

system

Win 10

Operating temperature

4–40 °C @ PP; 4–60 °C @ SS 316L

Min. circulation volume and

residual volume

Benchtop model for 0.1–0.5 m2 cassettes: min. circulation volume - 200 mL Benchtop model for 0.5–2.5 m2 cassettes: min. circulation volume - 400 mL

Language

Chinese/English, loaded with Chinese input methods

Material- liquid contact

part


316L, Polymer (USP class VI or FDA), EPDM, Santoprene elastomer, medical, Grade epoxy, silicone


Software Function of FiltraLinX® Semi-Automatic TFF System

  • Hierarchical alarm.

  • Three-tier access control.

  • Comply with the requirements on electronic record and electronic signature management in FDA 21 CFR Part 11.

  • Comply with audit trail requirements.

  • Display of process parameter trend charts with reports in PDF format.


PID Diagram of FiltraLinX® Semi-Automatic TFF System

pid diagram

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